# NVM: Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon

- Device class: 2; regulation: 21 CFR 870.1250; FDA's rule: 510(k) required
- FDA decisions: 5
- 510(k) review time 2021–2025: median 35 days (middle half 31–38)
- Recalls: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026; MAUDE to Sep 30, 2026

## Decisions per year (last 10)
- 2005: 1
- 2016: 2
- 2021: 1
- 2022: 1

## Most-cited predicates
- K050857: Bib Pta Balloon Catheter (2005), cited by 1

Source page: https://510kreport.com/product-code/NVM
Data by year (CSV): https://510kreport.com/product-code/NVM.csv